Associate II - Reg CMC Strategy
- India - Chennai
- India - Pfizer Centre
JOBSUMMARY
Provides functional support to the Brands CMC Strategist for the License Renewals and Annual Reports team, working closely with the CMC Global Regulatory Strategist – CMC (GRS‑CMC) and cross‑functional teams (RRHS/PCO/RCM/Site CNM) to prepare and submit CMC contributions for Renewal and Annual Report applications across global markets, in line with defined timelines.
JOBRESPONSIBILITIES
Manages day-to-day regulatory activities associated with assigned Renewals and Annual Reports within agreed upon timelines under the guidance of Team Lead / designee.
Renewals CMC Responsibilities:
Demonstrates Fundamental Knowledge of Process Principles and Concepts; Activities Include, but Are Not Limited to:
- Provides support to Renewal Strategists in the preparation of CMC contributions for renewal applications for assigned products across global markets.
- Authors and/or compiles CMC contributions for renewals, including Modules 1, 2.3.S/P, and 3.2.S/P/R/A; collaborates with GRS‑CMC and RRHS, as appropriate, and within agreed timelines.
- Liaises with Pfizer Global Supply and other support functions, as needed.
- Applies relevant regulatory guidelines in the authoring of renewal documentation.
- Executes the regulatory strategy for renewals while considering registered content and seeks endorsement from GRS‑CMC and/or RRHS; supports query and/or commitment management in collaboration with GRS‑CMC.
- Reviews technical and supporting information for submission to support renewal applications.
- Updates impacted dossier components, as required; escalates timeline delays and supports risk identification and mitigation in collaboration with the Team Lead (TL) or designee; flags identified risks to the CMC GRL and/or appropriate leadership.
- Coordinates Module 1 and Module 3.2.R ancillary documents, as needed.
- Coordinates internal document review and sign‑off activities.
- Utilizes Pfizer systems (e.g., PEARL, GDMS, PDM, SPA), as appropriate.
Annual Report (AR) CMC Responsibilities:
- Reviews changes implemented during the reporting period for completeness and accuracy; develops the initial Annual Report regulatory strategy while considering registered content and seeks endorsement from the CMC GRL.
- Authors and/or compiles CMC contributions based on changes made during the applicable reporting period (e.g., Modules 1 and 3), under the guidance of the CMC GRL, within agreed timelines.
- Reviews all relevant systems to confirm post‑approval changes submitted and approved, including commitments made and fulfilled.
- Reviews technical and supporting information for submission to support Annual Report changes.
- Manages and reviews stability contributions to ensure accuracy and consistency with approved commitments.
- Reviews and applies relevant U.S. regulatory guidelines to confirm appropriate Annual Reportable filing classifications.
- Develops technical justifications for changes for agency submission, as needed.
- Updates impacted dossier components, as required.
- Coordinates Module 3.2.R ancillary documents, as needed.
- Escalates timeline delays and flags identified risks to the CMC GRL and/or appropriate leadership.
- Coordinates internal document review and sign‑off activities.
- Utilizes Pfizer CMC systems (e.g., GDMS, PDM, SPA), as appropriate.
- Ensures compliance with Pfizer internal procedures and training SOPs (PLA).
QUALIFICATIONS/SKILLS
Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications and other job-related technical and managerial skills.
- Preferred Education:
Minimum – Undergraduate/Postgraduate in Pharmacy or Science
- Preferred Experience:
Minimum 2 - 4 Years in leading independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization
- Preferred Attributes:
Excellent oral and written English communication skills. Good conceptual, analytical, problem solving, and organizational skills. Good conceptual and reasoning skills. Attention to details.
- Technical Skills:
- Knowledge on Regulatory requirements of post approval changes for global market.
- Knowledge in retrieving information from company’s and regulatory agency databases.
- Basic level of knowledge on general standards, processes and policies of Pfizer/Pharmaceutical manufacturing Industry.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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Regulatory Affairs
Breakthroughs that change patients’ lives
Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.
Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:
“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.
“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.
“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.
Pfizer Research & Development
Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.
With an unwavering commitment to innovation, we use a multidisciplinary approach that blends scientific expertise, cutting-edge technologies, and strategic collaborations, igniting a powerful engine that propels groundbreaking discoveries into life-saving treatments for patients in need.
Through our relentless pursuit of progress, we envision a future where cutting-edge medicines pave the way to healthier, happier lives worldwide.
Benefits at Pfizer
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.
Our Competitive Benefits Programs help our colleagues by:
- Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
- Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
- Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
- And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
For U.S. based jobs, view an overview of Pfizer’s U.S. benefits program (opens in a new window)